ProCell Surgical has received CE-marked approval for its Sponge Blood Recovery Unit, allowing it to enter the European Union market.
The certification indicates that ProCell’s product complies with the EU’s Medical Devices Regulation (EU) 2017/745.
The company’s patented technology modernises the process of surgical sponge-blood recovery, enhancing intraoperative autotransfusion (IAT) systems in hospitals.
ProCell president and device co-inventor Robert Krensky said: “ProCell Surgical’s sponge blood recovery system brings the first automated innovation for sponge blood recovery directly to the operating room table.
“It is easy to operate and can be used repeatedly during its single-case use. ProCell essentially closes the technology gap that existed during this important preliminary phase of IAT.”
The unit is designed to replace the manual process of hand-wringing sponges to recover blood, which can then be reinfused into the patient.
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Commenting on the surgery team’s experience with ProCell, University Hospitals Cleveland Medical Center cardiac surgery chief Marc Pelletier said: “ProCell has become a fixture in cardiac surgery at University Hospitals, and an additional tool in the surgical management of complex cardiac surgeries. Our patients only stand to benefit from this type of innovative surgical product.”
The use of IAT in operating rooms is a routine practice that helps reduce the need for donor blood transfusions and their associated risks.
ProCell’s device is poised to become a vital component in patient blood management strategies, particularly when sponge blood can represent up to 50% of total blood loss during surgery.